Corrective & Preventive Actions (CAPA)

Description:

In this course we will discuss corrective and preventive action also called CAPA which are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice (GMP), and numerous ISO business standards that is critical to an organizations continuous improvement.

Curriculum for this course:
Introduction
Agenda 1 min 04 secs
Regulatory 1 min 30 secs
Regulatory explanation 1 min 50 secs
Only about compliance? 56 secs
The Basics: CA 45 secs
The Basics: PA 1 min 45 secs
Key concepts 1 min 30 secs
Systemic issues 1 min 30 secs
Non-systemic issues 1 min 40 secs
Systemic issues – product examples 1 min 30 secs
Systemic issues – process examples 52 secs
Module 1: Industry
Industry [Non]Compliance 1 min 02 secs
Process Requirements 1 min 23 secs
Process Requirements: FDA 1 min 23 secs
Process Requirements: ISO 13485 1 min 30 secs
Module 2: Sources
Sources 1 min 48 secs
Risk: Helping you manage 1 min 05 secs
The process 1 min 19 secs
First things first: understand 1 min 17 secs
Containment 1 min 19 secs
Scope analysis: Food for thought 1 min 30 secs
Module 3: Root Cause Analysis
Root cause analysis (definition) 1 min 30 secs
Root cause analysis – why? 2 min 30 secs
Root cause analysis: toolbox 1 min 40 secs
Root cause analysis: example 1 min 01 secs
Root cause analysis: example (5 Whys) 1 min 39 secs
The results 1 min 45 secs
Root cause analysis: Major tripping point 1 min 23 secs
Root cause analysis: final thoughts 1 min 50 secs
Module 4: Actions
Action 1 min 23 secs
Actions: more than just “To Do” 52 secs
Actions: A Tripping Point 50 secs
Module 5: Review
Review 1 min 02 secs
Management Review Input 39 secs
Actions > Effectiveness > Transition 1 min 02 secs
Module 6: Effectiveness
Effectiveness: expectations 2 min 30 secs
Effectiveness 1 min 30 secs
Effectiveness: simple? 1 min 20 secs
Actions / effectiveness: example 1 1 min 23 secs
Actions / effectiveness: example 2 1 min 30 secs
Inspection / audit focus 52 secs
Take-aways 1 min 02 secs
The future 1 min 02 secs
Conclusion 1 min 23 secs
Conclusion
Final Exam
Certification
Author:

Start Learning Today!

We’ve got pricing plans to suit everyone

View Our Pricing Plans